Rockford company seeks approval for TMJD device

Mike DeDoncker

Wednesday

Sep 30, 2009 at 12:01 AMSep 30, 2009 at 1:50 PM

Those looking to relieve the pain of temporomandibular joint disorder, commonly known as TMJD, soon might have a new tool at their disposal. Officials of Rockford-based Ascentia Health Inc. hope they are just weeks away from receiving U.S. Food and Drug Administration approval to begin marketing their Clayton Intra-Aural Device, or CID, an in-ear support that its inventor, audiologist Larry Clayton, hopes will create a major shift in how locking and malfunction of the jaw joint and its surrounding muscles is treated.

Those looking to relieve the pain of temporomandibular joint disorder, commonly known as TMJD, soon might have a new tool at their disposal.

Officials of Rockford-based Ascentia Health Inc. hope they are just weeks away from receiving U.S. Food and Drug Administration approval to begin marketing their Clayton Intra-Aural Device, or CID, an in-ear support that its inventor, audiologist Larry Clayton, hopes will create a major shift in how locking and malfunction of the jaw joint and its surrounding muscles is treated.

The current standard of treatment is a dental stabilization splint, an acrylic mold of a patient’s upper teeth also called a bite splint which prevents involuntary grinding together of the upper and lower teeth. TMJ also might be caused by dislocation of soft tissues or arthritis in the joint and stress which can cause the patient to tighten facial and jaw muscles or to clench their teeth.

Dentists fit about 4 million stabilization splints annually in the U.S. and they typically are worn only while the patient is asleep.

“The primary venue to treat TMJD now is dentistry,” Clayton said, “and bite splints do work. If we receive approval, we will be the only other medical device to treat TMJD.

“To this point, other doctors might diagnose TMJD, but they refer the patient to a dentist and wouldn’t treat it because the splint is in the mouth. With this treatment in a different part of the anatomy, there is a whole new opportunity for medical professionals to offer treatment.”

To apply for FDA approval, Ascentia was required to prove in clinical trials that its device — a small, hollow insert of medical grade polymers that is custom fitted to each patient’s ear canal — could produce results comparable to those achievable with a bite splint.

Clayton, Ascentia’s chairman, and Bill Coole, president and CEO of the company, said those results were shown in a four-month trial conducted in 2000 at the University of Pennsylvania School of Dental Medicine and in a three-pronged clinical trial from April 2008 to this January by the Mexican Institute of Clinical Research in Mexico City.

Based on the results of the Mexico City trial, Ascentia filed a 510K application with the FDA on June 24. Approval of the application will allow Ascentia, which Clayton said has spent $750,000 since 1998 to get to this point, to go into business. The CID is Ascentia’s first product and Coole said most of the company’s investors are Rockford-area residents.

The FDA, by its own rules, had 90 days to respond to the application and Clayton said the company received an inquiry from the FDA this week which delays approval.

In the University of Pennsylvania study, which involved eight patients, the CID’s mean improvement of TMJD symptoms on four different pain measurement scales was 55 percent.

The most improvement was 65 percent on the craniomandibular index, a clinician-reported measurement of palpitation of facial muscle and dysfunction and the one the FDA would require for trial validation.

Doctors who participated in the University of Pennsylvania study presented a paper in 2004 in which they said “the CID led to an overall reduction in pain and dysfunction of the temporomandibular joint” and that “the CID is a safe, effective modality for the treatment of TMJ.”

“This is a great statement,” Clayton said, “but the FDA was not going to give us clearance on a study of eight subjects. We actually had to compare it to something, and that something was the bite splint or stabilization splint.”

It took nearly eight years, he said, to raise the $600,000 needed for the comparative trial in Mexico City in which 60 patients used the CID, 60 used a stabilization splint and 30 used jaw exercises 10 times daily and facial muscle massage. The cost included paying to have the Mexico City orthodontist who oversaw the trial trained in applying the craniomandibular index.

If the company receives FDA approval, Clayton said, it would have to raise more money to finance a business plan. He said the company had considered manufacturing the devices locally but would probably outsource manufacturing in the early stages of business.

Coole said a company in Pennsylvania that made the devices used in the clinical trials and a second company in Colorado have expressed interest in manufacturing the devices if the company decides to keep the rights and outsource production.

Clayton said he hopes dentists would be interested in the device as an alternative to the stabilization splint and thinks otolaryngologists (ear, nose and throat specialists) might be interested in the treatment.

“We see our device as effective,” he said. “We know it’s comparable to the bite splint and it’s noninvasive.

“You can take it out if, for whatever reason, you don’t want to wear it, but on average in the study the subjects were wearing this 20 hours a day. They were wearing the bite splint about seven and a half hours a day, essentially sleeping time, so this can be a 24-hour treatment potential if the patient wishes. It has minimal interference and, aesthetically, it’s not visible so we think it has clear advantage for patient application and treatment of TMJ.”

Mike DeDoncker can be reached at (815) 987-1382 or mdedoncker@rrstar.com.

New TMJD treatment?

What is TMJD?: The temporomandibular joint (TMJ) connects the lower jaw to the temporal bone of the skull. TMJ disorders are problems of the jaw, jaw joint and/or the surrounding facial muscles that control chewing and moving the jaw.
Causes: Injury to the jaw joint or muscles of the head or neck; grinding or clenching teeth; dislocation of the soft tissue in the joint; arthritis in the joint; stress.
Symptoms: Pain or tenderness in the face, jaw joint, neck or shoulders; limited ability to open the mouth; jaws get stuck or locked in a position; clicking, popping or grating sounds in the jaw joint; a tired feeling in the face; difficulty chewing or a sudden uncomfortable bite.
New treatment device: The Clayton Intra-Aural Device, or CID, is a small, hollow prosthesis made of medical grade polymers that is custom-fitted for insertion into the patient’s ear canal. It can be worn as much or as little as the patient wants.
Who: The CID is the first product of Ascentia Health Inc., a Rockford-based company with Larry Clayton, The Cid’s inventor, as chairman and Bill Coole as president and CEO.
More information: E-mail info@ascentia health.com.

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